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FDA 510(k)

SONAFINE WOUND DRESSING

K-Number: K110172 · 2011-08-19

ApplicantStratus Pharmaceutical
Decision Date2011-08-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SONAFINE WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Stratus Pharmaceutical. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K110172. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONAFINE WOUND DRESSING?

SONAFINE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Stratus Pharmaceutical. The 510(k) number is K110172.

When did SONAFINE WOUND DRESSING receive FDA 510(k) clearance?

SONAFINE WOUND DRESSING received FDA 510(k) clearance on 2011-08-19, under 510(k) number K110172.

Who is the listed applicant for SONAFINE WOUND DRESSING?

The FDA 510(k) record lists Stratus Pharmaceutical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONAFINE WOUND DRESSING?

The FDA product code for SONAFINE WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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